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DEXEDRINE

ANDA

DEXTROAMPHETAMINE SULFATE | A083902 | GLAXOSMITHKLINE

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Arnall Golden Gregory LLP FDA-2022-P-0509 · 8 docket documents Arnall Golden Gregory LLP filed this citizen petition requesting that the FDA establish new science-based regulatory limits to control the impurity 2-methyl-3-phenylaziridine in amphetamine salts active pharmaceutical ingredients used in ADHD medications such as Adderall and Dexedrine. The petitione	Other	2022-04-01	Open	Arnall Golden Gregory LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Medicare Part D Spending

CMS annual spending data for Dexedrine (2024)

Total Spending

$509K

Total Claims

254

Beneficiaries

Avg Cost/Unit

$22.37

Spending Trend

$2.1M(2019)→$2.9M(2020)→$2.7M(2021)→$2.7M(2022)→$2.3M(2023)→$509K(2024)

YoY Change:-7.0%

5yr CAGR:-0.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs1 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

VERANOVA LPDEXTROAMPHETAMINE SULFATE

DMF 147832000

CAMBREX CHARLES CITY INCDEXTROAMPHETAMINE SULFATE USP

DMF 153072001

SPECGX LLCDEXTROAMPHETAMINE SULFATE USP

DMF 153852001

CURIA NEW YORK INCDEXTROAMPHETAMINE SULFATE USP

DMF 160212002

VERANOVA LPDEXTROAMPHETAMINE SULFATE USP

DMF 235832010

SIEGFRIED USA LLCDEXTROAMPHETAMINE SULFATE

DMF 296042016

CHATTEM CHEMICALS INCDEXTROAMPHETAMINE SULFATE USP

DMF 312442017

ISP FREETOWN FINE CHEMICALS INCInactiveDEXTROAMPHETAMINE SULFATE

DMF 156072001

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

ELIXIR;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.